The present invention is generally in the field of homeostatic devices and in particular it is directed to a sealing device for sealing a puncture (incision) in a blood vessel of a patient during or after a medical procedure. The invention is also concerned with a deploying member and a method for deploying the sealing device.
During several surgical procedures carried out, for example in treatment of vascular diseases, it is common practice to invade a blood vessel and introduce a treating or diagnostic device, e.g. balloons or various types of stents to operate on walls of the arteries, plaque removing devices, observation and flow diagnostic instruments, etc.
During such procedures, a blood vessel is punctured so as to allow introduction of the instrument through the artery and then maneuver it to the required site of operation. This is carried out in practice by introducing a guide tube often referred to as an xe2x80x9cintroducer sheathxe2x80x9d, through which the instrument can then be easily maneuvered to the site of interest.
A problem occurs once the procedure is complete and the guide tube has then to be removed, when the percutaneous puncture bleeds. Bleeding may result in hematoma or in severe cases to malfunction of critical organs and even death. Such bleeding is stopped, by a most common method, by simply applying pressure on to the puncture site by a medically trained person for a sufficiently long period of time until homeostasis takes place to spontaneously seal the puncture and stop the bleeding.
In cases of puncturing the femoral arteries, the required time may be as long as about 45 minutes or more and in some cases re-bleeding occurs if the patient is not in rest.
A variety of methods and devices have been suggested for replacing the traditional method disclosed above, some of which involve introducing chemical compounds which act as homeostasis catalysts or as adhering agents, whilst others aim at introducing various forms of plugging members into the puncture. The following is a list of prior art patents disclosing devices and methods for sealing punctured blood vessels: U.S. Pat. Nos. 4,705,040 4,890,612, 4,929,246, 5,108,420, 5,342,393, 5,350,399, 5,391,183, 5,613,974, 5,810,884, 5,861,003, 5,957,952, 5,984,950, 6,007,563 and WO 98/31287.
It is an object of the present invention to provide a novel and inventive device for sealing a puncture or incision formed in a blood vessel or in other body organs as well as an associated deploying member for deploying the sealing member into a sealing position. A further object of the invention is to provide a method utilizing the sealing member and the associated deploying assembly.
The present invention calls for a sealing device and an associated deploying assembly, as well as a method for sealing a puncture or an incision formed in a body organ, typically but not limited, in a blood vessel.
By one important feature the present invention, the sealing device is introduced into the puncture over a guide tube (sheath) used for carrying out a medical procedure e.g. angioplasty, in which a probe is introduced into a blood vessel through the guide tube. The sealing member of the present invention is received within a deploying member used for displacing the sealing member into the puncture site and then deploying it into its operative-sealing position, in which it is anchored within the puncture and seals the puncture-incision. The sealing device is fitted with anchoring means to ensure suitable anchorage within the puncture and is useful for a variety of guide tubes on the one hand and for a variety of wall thicknesses of the blood vessel at the puncture site, on the other hand.
In accordance with the present invention there is provided a sealing device for sealing a puncture in a blood vessel, the device being slidingly receivable over a guide tube and comprising a tubular, resilient sealing member formed with a sealing portion spontaneously sealable upon deployment of the device into an activated state, an engaging portion for bearing against an external surface of the blood vessel and a plurality of anchors fitted at their fore end with fasteners for engaging a corresponding internal surface of the blood vessel and at a rear end with a manipulating bit; said anchors being displaceable between a constricted position in which they blend with the tubular sealing member, and an operative position in which the fasteners are laterally expanded and engage the internal surface of the blood vessel.
The present invention also suggests a unique application of a sealing device fitted with means for grabbing tissue of a blood vessel (or any other organ being sealed) surrounding the puncture (i.e. lip or edges of the puncture) and applying force in direction so as to adjoin edges of the puncture, thus reducing the section area of the puncture and speeding the sealing process.
In accordance with a first embodiment of that application, the fasteners are fitted with spikes facing rearwards for engaging tissue of the blood vessel, wherein at the deployed state the anchors are biased radially inwardly, for constricting the size of the puncture in the blood vessel.
According to a second embodiment of that application, there are provided several spears axially displaceable with respect to the resilient sealing member, said spears having a fore end fitted for grabbingly engaging the external tissue surface of the blood vessel at locations peripheral to the puncture. At least said fore end being displaceable radially inwardly so as to decrease the imaginary delimited circle defined by the spears.
The radial inward force applied to the anchor disclosed in the above said first embodiment and to the spears disclosed in the present second embodiment is delivered by the formation of the resilient sealing member which deforms in a manner in which it constricts its diameter adjacent its fore end.
In accordance with another embodiment of the invention, the engaging portion of the sealing member is truncated such that when it is engaged with the blood vessel, the sealing member bears at an inclination over the blood vessel. Accordingly, the fasteners are axially graded, giving rise to an imaginary path extending between edges thereof, said path conforming with the truncated edge of the sealing member.
The sealing device of the present invention is deployable into its operative position by a deploying assembly comprising a tubular housing, a tubular controller received within the housing and a tubular pusher member received within the controller, coaxially received within one another; said pusher adapted for manipulating the sealing member into its activated position.
By manipulating the controller and pusher of the deploying assembly, the sealing member is displaced into the puncture site. The pushing member is fitted with activating surfaces which are fitted with gliding surfaces inclined so as to engage with the manipulating bits at their constricted position and where rotation of the pusher member entails sliding displacement of the manipulating bits about said activating surfaces thereby deploying the anchors into their operative position.
According to one particular embodiment the pusher member also activates the tissue grabbing means into engagement with tissue of the blood vessel surrounding the puncture.
The present invention call also for a method for sealing a puncture in a blood vessel, the method comprising the following steps:
(a) Obtaining a sealing assembly comprising a sealing member fitted within an associated deploying assembly, with a sleeve extending through the sealing assembly, said sleeve defining a through-going path;
(b) Introducing a medical guide tube through the path;
(c) Removing the sleeve;
(d) Carrying out a medical procedure trough the guide tube:
(e) Slidingly displacing the sealing assembly over the guide tube until a fore end of the deploying assembly engages the blood vessel;
(f) Expelling the sealing assembly from the deploying assembly and introducing anchor fastener members of the sealing assembly into the blood vessel through the puncture;
(g) Deploying anchor fastener members into an operative position in which they are laterally expanded and engage the internal surface of the blood vessel;
(h) Disengaging the sealing assembly from the deploying assembly and withdrawing the guide tube, allowing a resilient sealing member formed in the sealing member to spontaneously seal.
According to a particular embodiment at step (d) the guide tube is inserted into the blood vessel at an angle corresponding with a truncation angle of an engaging portion formed at the sealing member, for bearing against an external surface of the blood vessel.
Furthermore, at least step (e) is radio-monitored, whereby at least a fore end of the housing is made of or fitted with a radio-opaque material.
According to a modification of the invention, after the device has been deployed into the puncture site, tissue grabbing means are engaged with the tissue surrounding the puncture and upon applying thereto an inwardly directed radial force, the puncture size is decreased. The tissue grabbing means are either internal spikes e.g. formed on the fasteners and adapted for engaging al internal wall surface of the blood vessel, or spear-like members for engaging external wall surface of the blood vessel.
According to one particular embodiment, where the fasteners are fitted with rearwardly facing spikes, after step (e) axial force is applied to the sealing member in a rearward direction, thereby having the spikes engage tissue of the blood vessel.